Seroconversion rates at day 22b
Data reflect results from a pivotal trial that evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU®. A total of 7082 subjects were randomized and vaccinated with FLUAD (N=3541) or AGRIFLU (N=3541).
CI=confidence interval; GMT=geometric mean antibody titer; HI=hemagglutinin inhibition; N=the number of vaccinated participants with available data from the immunologic endpoint listed.
aAGRIFLU. bFLUAD met non-inferiority criteria based on seroconversion rate differences if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was ≥10%. cFLUAD met non-inferiority criteria based on GMT ratios if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was >0.67.
GMT and GMT ratios at day 22c
Data reflect results from a pivotal trial that evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU®. A total of 7082 subjects were randomized and vaccinated with FLUAD (N=3541) or AGRIFLU (N=3541).
CI=confidence interval; GMT=geometric mean antibody titer; HI=hemagglutinin inhibition; N=the number of vaccinated participants with available data from the immunologic endpoint listed.
aAGRIFLU. bFLUAD met non-inferiority criteria based on seroconversion rate differences if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was ≥10%. cFLUAD met non-inferiority criteria based on GMT ratios if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was >0.67.

DEMONSTRATED SAFETY PROFILE

FLUAD safety profile established in randomized clinical trials.1
FLUAD has a similar safety profile to that of a non-adjuvanted, standard-dose influenza vaccine.
Most common (≥10%) local and systemic adverse reactions observed within 7 days of vaccination with FLUAD or non-adjuvanted, standard-dose influenza vaccine.1
While more frequent injection-site-related events were reported for FLUAD, most were mild to moderate.1
The safety of FLUAD and FLUAD QUADRIVALENT was evaluated in 17 clinical studies in 10,911 adults 65 years of age and older.
Data for FLUAD QUADRIVALENT are relevant to FLUAD because both vaccines are manufactured using the same process and have overlapping compositions.
310+ MILLION DOSES DISTRIBUTED WORLDWIDE2
*Doses distributed globally as of November 2023 and includes both FLUAD and FLUAD QUADRIVALENT.
Choose FLUAD for your eligible patients 65+ years1
  • Covered by Medicare Part B and by most Medicare Advantage Plans with no copay*
  • CPT reimbursement code
    • Single-dose syringe: 90653
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*This information does not constitute a guarantee or warranty of coverage benefits or reimbursement.

INDICATION AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not administer FLUAD or AFLURIA to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.

Do not administer FLUCELVAX to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

WARNINGS AND PRECAUTIONS

If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of previous influenza vaccine, the decision to give FLUAD, FLUCELVAX, or AFLURIA should be based on careful consideration of the potential benefits and risks.

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUAD, FLUCELVAX, or AFLURIA.

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

The immune response to FLUAD, FLUCELVAX, and AFLURIA in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.

Vaccination with FLUAD, FLUCELVAX, or AFLURIA may not protect all vaccine recipients against influenza disease.

ADVERSE REACTIONS

FLUAD:

The most common (≥ 10%) local and systemic adverse reactions in adults 65 years of age and older who received FLUAD were injection site pain (25%), injection site tenderness (21%), myalgia (15%), fatigue (13%) and headache (13%). Other adverse events may occur.

FLUCELVAX:

Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions.

In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28%), erythema (26%), induration (17%) and ecchymosis (11%). The most common systemic adverse reactions were irritability (28%), sleepiness (27%), diarrhea (18%) and change of eating habits (17%).

In children 4 through 8 years of age who received FLUCELVAX, the most commonly reported local injection-site adverse reactions were pain (29%) and erythema (11%). The most common systemic adverse reaction was fatigue (10%).

In children and adolescents 9 through 17 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (34%) and erythema (14%). The most common systemic adverse reactions were myalgia (15%) and headache (14%).

In adults 18 through 64 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (28%) and erythema (13%). The most common systemic adverse reactions were headache (16%), fatigue (12%), myalgia (11%) and malaise (10%).

In adults ≥ 65 years who received FLUCELVAX the most commonly reported injection-site reaction was erythema (10%). The most common systemic adverse reactions were fatigue (11%), headache (10%) and malaise (10%).

Other adverse events may occur.

AFLURIA:

Data for AFLURIA QUADRIVALENT are relevant to AFLURIA because both vaccines are manufactured using the same process and have overlapping compositions.

Administered by needle and syringe (AFLURIA QUADRIVALENT data):

In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%). The most common systemic adverse reactions were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).

In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse reactions were malaise and fatigue, and diarrhea (≥ 10%).

In children 5 through 8 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reaction was headache (≥ 10%).

In children 9 through 17 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reactions were headache, myalgia, and malaise and fatigue (≥ 10%).

In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (≥ 40%). The most common systemic adverse reactions were myalgia and headache (≥ 20%).

In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥ 20%). The most common systemic adverse reaction was myalgia (≥ 10%).

Administered by the PharmaJet Stratis Needle-Free Injection System:

In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse reactions were myalgia, malaise (≥ 30%), and headache (≥ 20%).

Other adverse events may occur.

To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Before administration, please see the full US Prescribing Information for FLUAD, FLUCELVAX and AFLURIA.

PharmaJet® and STRATIS® are registered trademarks of PharmaJet.

References : 1. FLUAD. Package insert. Seqirus Inc 2. Data on file. Seqirus Inc; 2023.